**Exhibit 10. 4**

 

Confidential Materials omitted and filedseparately with theSecurities and Exchange Commission. Asterisks denote omissions.

 

**FIRST AMENDMENT TO DISTRIBUTION AGREEMENT**

 

This FIRST AMENDMENT TO DISTRIBUTION AGREEMENT, is made and entered intoas of February 24, 2004 (this “Amendment”), by and among EdwardsLifesciences LLC, a Delaware limited liability company (“Edwards”), PLC SystemsInc., a Yukon Territory corporation (“PLC Parent”), and PLC Medical Systems,Inc., a Delaware corporation (“PLC”).  *Certain capitalized terms used herein have themeanings ascribed to them in the Agreement (defined below).*

 

**RECITALS**

 

WHEREAS, the parties hereto have previously entered into a DistributionAgreement, dated as of January 9, 2001, by and among Edwards, PLC Parentand PLC (the “Agreement”); and

 

WHEREAS, the parties hereto desire to amend certain provisions of theAgreement pursuant to Section 11.11 thereof.

 

**AGREEMENT**

 

NOW, THEREFORE, in consideration of the foregoing and the respectivecovenants and agreements set forth herein, and for other good and valuableconsideration, the receipt and sufficiency of which are hereby acknowledged,the parties hereto agree as follows:

 

1.                                       AMENDMENTOF AGREEMENT.  The Agreement is herebyamended as follows:

 

1.1.                              Section 7.1(a) ofthe Agreement is hereby amended and restated in its entirety to read asfollows:

 

“Edwards shall purchase the TMR Disposable Kits from PLC at 36.5% ofthe Average End User Price.  The“Average End User Price” shall mean the average of the actual sales price foreach TMR Disposable Kit sold during a calendar quarter.  Edwards shall calculate the Average End UserPrice and deliver such calculation to PLC within 15 days after the end of eachquarter.”

 

1.2.                              The first sentence ofSection 7.1(b) of the Agreement is hereby amended and restated in itsentirety to read as follows:

 

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“PLC shall bill TMR Disposable Kits to Edwards on a preliminary basisat 36.5% of the Estimated End User Price.”

 

1.3                                 Section 8.1 ofthe Agreement is hereby deleted in its entirety and restated to read asfollows:

 

“*Term and Renewal.*  This Agreement shall commence on the datehereof (the “Effective Date”) and shall continue for the enforceable life ofthe last to expire of the United States patents held by PLC related to theProducts.”

 

2.                                       PAYMENTOF CONSIDERATION FOR AMENDMENT.  Inconsideration of the amendments to the Agreement contained in Section 1above, concurrently with execution of this Amendment, Edwards will pay to PLCthe sum of four million five hundred thirty-three thousand three hundredthirty-three dollars ($4,533,333) by wire transfer of immediately available andnon-refundable funds.

 

3.                                       MISCELLANEOUS.

 

3.1                                 Governing Law.  This Amendment shall be governed by,interpreted under, and construed in accordance with the internal laws of theState of New York, including, without limitation, Sections 5-1401, 5-1402 ofthe New York General Obligations Law and New York Civil Practice Laws and Rules327(b).

 

3.2                                 Counterparts.  This Amendment may be executed in two ormore counterparts, each of which shall be deemed an original and all of whichshall, taken together, be considered one and the same amendment, it beingunderstood that the parties need not sign the same counterpart.

 

3.3                                 Severability.  In the event that any one or more of theprovisions contained herein, or the application thereof in any circumstances,is held invalid, illegal or unenforceable in any respect for any reason, theparties shall negotiate in good faith with a view to the substitution thereforeof a suitable and equitable solution in order to carry out, so far as may bevalid and enforceable, the intent and purpose of such invalid provision; *provided, however*, that the validity,legality and enforceability of any such provision in every other respect and ofthe remaining provisions contained herein shall not be in any way impairedthereby, it being intended that all of the rights and privileges of the partieshereto shall be enforceable to the fullest extent permitted by law.

 

3.4                                 Ratification andReaffirmation.  Except as otherwiseexpressly provided herein, the Agreement remains in full force and effectunamended, and all of the terms and provisions of the Agreement, as modified bythis Amendment, are hereby ratified and reaffirmed by Edwards, PLC Parent andPLC.  All references to the Agreementcontained in the Agreement shall mean the Agreement as modified hereby.

 

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IN WITNESS WHEREOF, the parties have caused this Amendment to be dulyexecuted and delivered, all as of the date first set forth above.

 
|   | EDWARDS LIFESCIENCES LLC |
|--------|--------------------------|
|   |                     |   |
|   |                     |   |
|   | By:                      |   | /s/John H. Kehl, Jr. |   |
|   | Name:                    | John H. Kehl, Jr. |
|   | Title:                   | Corporate Vice President,  Strategy and Business Development |
|   |                     |   |
|   |                     |   |
|   | PLC SYSTEMS INC.         |
|   |                     |   |
|   |                     |   |
|   | By:                      |   | /s/James G. Thomasch |   |
|   | Name:                    | James G. Thomasch |
|   | Title:                   | Senior Vice President &  Chief Financial Officer |
|   |                     |   |
|   |                     |   |
|   | PLC MEDICAL SYSTEMS INC. |
|   |                     |   |
|   |                     |   |
|   | By:                      |   | /s/James G. Thomasch |   |
|   | Name:                    | James G. Thomasch |
|   | Title:                   | Senior Vice President &  Chief Financial Officer |
|        |                          |  |  |  |  |  |

 

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